FDA.reportPublic FDA data

Extraction Tool

Primary DI
05065012584226
Brand
Extraction Tool
Company
EVENTUM ORTHOPAEDICS LTD
Model
ET001
Device description
Tool for dismantling patella spacers
Published
2025-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05065012584226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05065012584226050650125842265065012584226

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant/instrument dismantling deviceA device designed to dismantle (take apart) the component parts of an implant or a surgical instrument that have previously been assembled. It may be used as a stand-alone device or in combination with another device to control the dismantling process of, e.g., complex implants (e.g., a modular vertebral implant that has to be dismantled if the combination of the component parts do not fit the required size) or instruments so that these are correctly disassembled, without causing damage to any of the parts. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of shapes and lengths. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+442045428754regulatory@eventumortho.com

Regulatory Flags#

DUNS number
226230358
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05065012584257Reusable 5mm Pro ShimRS5002026-02-05
05065012584264Reusable 5mm 2.5 degree Pro shimRS50A2026-02-05
05065012584271Reusable 6mm Pro shimRS6002026-02-05
05065012584288Reusable 6mm 2.5 degree Pro shimRS60A2026-02-05
05065012584295Reusable 7mm Pro shimRS7002026-02-05
05065012584301Reusable 7mm 2.5 degree Pro shimRS70A2026-02-05
05065012584318Reusable 8mm Pro shimRS8002026-02-05
05065012584325Reusable 8mm 2.5 degree Pro shimRS80A2026-02-05
05065012584493Quadsense ProSE0022025-04-04
05065012584189Reusable 6mm shimRS0012025-02-19
05065012584196Reusable 7mm shimRS0022025-02-19
05065012584202Reusable 6mm 2.5 degree shimRS0032025-02-19
05065012584219Reusable 7mm 2.5 degree shimRS0042025-02-19
05065012584332-1mm Cutting Guide Depth AdaptorDA0112025-02-19
05065012584349-2mm Cutting Guide Depth AdaptorDA0122025-02-19
05065012584356-3mm Cutting Guide Depth AdaptorDA0132025-02-19
05065012584363-4mm Cutting Guide Depth AdaptorDA0142025-02-19
05065012584387-6mm First Cut AdaptorGG0162025-02-19
05065012584394-7mm First Cut AdaptorGG0172025-02-19
05065012584455Cutting Guide Angle Adaptor LM 2.5 DegreeAA0152025-02-19

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10886982362179NASynthes GmbHLXH2026-07-24
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B382SD9141071030Surgical DirectSurgical Direct, Inc.LXH2026-07-24
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